Home NDC 68788-8125-3 Azithromycin
Product NDC 68788-8125
Requested package NDC 68788-8125-3
11-digit product format 687888125
Labeler code 68788
Product ID 68788-8125_661ff7a6-6394-493d-a307-a1f607e5d117
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA065212
Marketing category ANDA
Marketing start 2022-01-10
Marketing end 0000-00-00
Substance AZITHROMYCIN MONOHYDRATE
Active strength 500 mg/1
Pharmacologic classes Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065212-001 AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065212-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065212-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2005-11-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Azithromycin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZITHROMYCIN DIHYDRATE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5FD1131I7S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 248656 Internal RxNorm lookup 308460 Internal RxNorm lookup 749780 Internal RxNorm lookup 749783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-8125-3 Azithromycin 3 in 1 DOSE PACK TABLET, FILM COATED 3 1 68788-8125-3 Azithromycin 1 in 1 CARTON TABLET, FILM COATED 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8125 AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] 1 Legacy NDC, 2 package rows 20220111_661ff7a6-6394-493d-a307-a1f607e5d117.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-8125-3 68788812503 1 DOSE PACK in 1 CARTON (68788-8125-3) > 3 TABLET, FILM COATED in 1 DOSE PACK 1 dose pack 2022-01-10 0000-00-00 No No Current